Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation (OPTIMIZE-PCI)

Optimization of Percutaneous Coronary Intervention After Stent Implantation With Liberal Use of High-pressure Non-compliant Balloon Post-dilatation Versus Contemporary Practice

To achieve optimal long-term clinical results after percutaneous coronary intervention (PCI), adequate deployment of stents is essential. Thorough expansion of the stent and full apposition of stent struts against the vessel wall are determining factors for preventing stent thrombosis and restenosis for bare-metal as well as drug-eluting stents (DES). Standard coronary angiography is limited in assessing accurate vessel size and characterizing tissues and calcium load. Therefore, stent underexpansion frequently occurs after stent deployment.

Post-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts, aiming to reduce stent thrombosis and restenosis both short term as long term. However, there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes. As a result of the restricted evidence, there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear.

For this reason, the OPTIMIZE PCI was designed, a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple PCI centers in the Netherlands. As part of the OPTIMIZE-PCI, a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of major adverse cardiac events.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Liberal post-dilatation strategy during PCI

Detailed Description

The Netherlands Heart Registration (NHR) is an independent organization in which Dutch hospitals prospectively register standard sets of baseline, procedural and outcome data for all invasive cardiac procedures, including PCI. Data provided to the NHR are extensively checked on completeness and quality, reviewed with audit reports by independent trained research nurses and discussed by cardiologists in registration committees. Multiple audits are conducted annually by the NHR for data validation and verification. A waiver for informed consent for analysis with the data of the NHR data registry is obtained.

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: K Teeuwen, MD, PhD; Phone Number: + 31 040 239 9111; Email: koen.teeuwen@catharinaziekenhuis.nl
• Study Contact Backup: Name: K.A.J. Beek, MD; Phone Number: + 31 040 239 9111; Email: konrad.v.beek@catharinaziekenhuis.nl

Study Locations

• Netherlands
  • North- Brabant
    • Eindhoven, North- Brabant, Netherlands, 5623 EJ
      • Recruiting
      • Catharina Hospital
      • Contact: Koen Teeuwen, MD, PhD; Phone Number: 040-2398360
      • Contact: Konrad van Beek, MD; Phone Number: 040 239 9111; Email: konrad.v.beek@catharinaziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population exists of patients registered in our national PCI registration of the Netherlands Heart Registration after receiving PCI. All indications are included (ACS and non-ACS, OHCA, cardiogenic shock), resulting in an all-comer population

Description

Inclusion Criteria:

• All patients >18 years old who undergo PCI for any indication are included in the register of the Netherlands Heart Registration and therefore included in the final analysis of this project

Exclusion Criteria:

- If a patient has multiple PCIs within 365 days, only the first procedure is included.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-intervention/implementation cohort; In the first phase, data additional to the national PCI registry will be analyzed retrospectively from all patients receiving PCI from January 2021 to January 2022. Data on the percentage of use of post-dilatation using high-pressure non-compliant (HPNC) balloon by the individual interventional cardiologist will be collected. This will establish a benchmark from which individual interventional cardiologists must increase their use of post-dilatation.
Post-intervention/implementation cohort; During this implementation phase, all individual PCI operators of the participating centres will be informed to liberally use post-dilatation for stent optimization during PCI. Operators are requested to increase their use of post-dilatation with at least 20% or use post-diltation in at least 85% of the PCI's. Throughout the project, individual participating operators will receive individual feedback on the percentage use of post-dilatation with prospective data collection after 2, 4, 6, 9 and 12 months. Based on this result, the implementation process will be refined as necessary. The duration of this phase will be approximately 1 year per centre. Eventually a retrospective observational anlaysis, comparing the two cohorts, will be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of major adverse cardiac events.	Behavioral: Liberal post-dilatation strategy during PCI; A liberal post-dilatation strategy for stent optimization during PCI will be implemented in multiple centers in the Netherlands. This include an increase of post-dilatation use of at least 20% per operator, or a percentage of post-dilatation of at least 85%. Operators will be asked to enforce a very low threshold for post-dilatation in general, with a mandatory HPNC post-dilatation for the following indications: In case of any calcification; Delta of ≥ 0.5mm between the distal and proximal reference diameter of the treated coronary segment; Stent length >24 mm; Signs of incomplete stentframe-deployment on angiography or StentBoost; In case of CTO; In case of bifurcation PCI (Left main and non-left main)Proximal Optimisation Technique (POT) with NC balloonFinal Kissing Balloon dilatation (FKB) with preferentially first sequential high-pressure inflations and final low pressure kiss both with NC balloons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality	The primary composite end point of major adverse cardiac events is the occurrence of target vessel revascularization, myocardial infarction and all-cause mortality.	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	all cause mortality, confirmed by verifying the vital status of a patient in the Personal Records Database.	30 days, 1 year
Target vessel revascularization	Target vessel revascularization, defined as a revascularization by percutaneous coronary intervention or coronary artery bypass grafting in the same vessel(s) that had been treated at the index procedure, excluding staged procedures.	30 days and 1 year
Myocardial infarction	Myocardial infarction, defined as an increase and/or decrease in one or more cardiac biomarkers by at least one value above the 99th percentile of the upper limit where at least one of the following symptoms is present: 1) symptoms appropriate to ischemia, 2) new significant ST-segment or T-wave abnormalities or bundle branch block, 3) development of pathological Q-waves on the electrocardiogram (ECG), 4) imaging demonstrated new loss of viable myocardial tissue or new wall motion abnormalities, 5) identification of intracoronary thrombus on angiography or autopsy.	30 day

Collaborators and Investigators

• Sponsor: Cathreine BV
• Collaborators: Medtronic

Publications and helpful links

General Publications

• van Beek KAJ, Timmermans MJC, Derks L, Cheng JM, Kraaijeveld AO, Arkenbout EK, Schotborgh CE, Brouwer J, Claessen BE, Lipsic E, Polad J, van Nunen LX, Sjauw K, van Veghel D, Tonino PA, Teeuwen K; 'on behalf of the PCI registration committee of The Netherlands Heart Registration'. Contemporary Use of Post-Dilatation for Stent Optimization During Percutaneous Coronary Intervention; Results From the Netherlands Heart Registration. Catheter Cardiovasc Interv. 2025 Mar;105(4):870-877. doi: 10.1002/ccd.31404. Epub 2025 Jan 8.
• Slingerland SR, van Beek KAJ, Schulz DN, van Steenbergen GJ, Brouwer T, Stoel M, Vlaar PJ, Tonino PA, Dekker L, van Nunen LX, Teeuwen K, van Veghel D. Results of systematic patient outcome monitoring: Does post-dilatation during angiography-guided percutaneous coronary intervention improve clinical outcomes? Hellenic J Cardiol. 2025 Mar-Apr;82:26-33. doi: 10.1016/j.hjc.2023.11.004. Epub 2023 Nov 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery disease; post-dilatation; stent optimization
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Dilatation, Pathologic
• Other Study ID Numbers: CathreineBV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No